RTOG 9804: A prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation Journal Article
| Authors: | McCormick, B.; Winter, K.; Hudis, C.; Kuerer, H. M.; Rakovitch, E.; Smith, B. L.; Sneige, N.; Moughan, J.; Shah, A.; Germain, I.; Hartford, A. C.; Rashtian, A.; Walker, E. M.; Yuen, A.; Strom, E. A.; Wilcox, J. L.; Vallow, L. A.; Small, W. Jr; Pu, A. T.; Kerlin, K.; White, J. |
| Article Title: | RTOG 9804: A prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation |
| Abstract: | Purpose The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation. Patients and Methods This prospective randomized trial (1998 to 2006) in women with mammographically detected lowor intermediate-grade DCIS, measuring less than 2.5 cm with margins - 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method. Results Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P <.001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients. Conclusion In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted. © 2015 by American Society of Clinical Oncology. |
| Keywords: | adult; major clinical study; cancer risk; united states; cancer radiotherapy; disease free survival; follow up; prospective study; breast cancer; partial mastectomy; tamoxifen; kaplan meier method; acute toxicity; canada; intraductal carcinoma; randomized controlled trial (topic); human; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 33 |
| Issue: | 7 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2015-03-01 |
| Start Page: | 709 |
| End Page: | 715 |
| Language: | English |
| DOI: | 10.1200/jco.2014.57.9029 |
| PROVIDER: | scopus |
| PMCID: | PMC4334775 |
| PUBMED: | 25605856 |
| DOI/URL: | |
| Notes: | Export Date: 2 April 2015 -- Source: Scopus |
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